JPS60500844A - rectal massage device - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] rectal insert Background of the invention Hemorrhoids are swollen varicose veins in the mucous membranes inside or outside the rectum.

One of the typical causes of hemorrhoids is constipation and the urge to defecate hard, dry stools. It is the force of time. The excess pressure causes the folds of the membranous rectal lining to separate, opening the veins. Tighten and stimulate this.

Pregnant women are more susceptible to hemorrhoids due to pressure on the veins in the lower body.

Other causes of hemorrhoids include anal infections caused by gastrointestinal disorders and liver cirrhosis. There is. It blocks the blood and puts pressure on the hemorrhoidal veins.

When hemorrhoids form, they can be caused by constipation, added pressure from straining to defecate, or long-term problems. Exacerbated by external pressure from prolonged sitting, rupture occurs.

Bursting and bleeding hemorrhoids are susceptible to infection; swelling due to inflammation can also put pressure on the veins, making the hemorrhoids worse. let

Hemorrhoids are a self-accelerating disease, and prevention of progressive deterioration makes treatment successful. This is an essential condition for

Treatment methods for hemorrhoids that suppress bleeding and eliminate varicose veins include warm baths, ointments, suppositories, surgery, There are injection chemotherapy, etc., but when several treatment methods are combined depending on the symptoms There are also quite a few.

One treatment is to cool the hemorrhoid tissue to relieve pain and reduce swelling. . For example, Cowie, in U.S. Pat. No. 969,134, Those who use a hollow insert that allows ice or other refrigerant to be replaced and filled each time it is used. Discloses the law.

Also, recently, Harris published US Patent No. 3,939°842. a collapsible spherical end which encloses a freezing liquid (preferably water); A plastic rectal insert is disclosed. Both of these inserts are as follows: It has some common deficiencies: (1) The surface temperature of the insertion tool may become very low, which may cause sensitive There is a risk of frostbite of rectal tissues. Frostbite occurs when the fluid inside cells freezes, causing small Destroys the cell membrane. When the contact between the insert and the rectal tissue is close and the heat transfer rate is high. can cause frostbite even at temperatures below 0°C; This is exactly the case.

(2) Both of the two insertion tools are used in a serious sense and are not official, so they cannot be reused. There is a high risk of infection due to Harris' inserts are meant to be disposable. However, there are no measures taken to prevent reuse, and they are more expensive than ointments or suppositories. Therefore, the possibility of reuse is extremely high.

(3) Both inserts are single-function devices that only cool the tissues of the rectal canal. child Insert therapy involves administering certain drugs, a protective/lubricating layer to the swollen tissue, and Some supplement this treatment by softening the stool and may also relieve discomfort. Other treatments, such as ointments, lubricants, and suppositories, must be used to protect the skin.

(4) Both inserts must be lubricated.

Therefore, the cooling effect of the freezing liquid enclosed in the solid shell is not fully exerted. , and may involve some kind of danger.

Because of their shape, suppositories cannot be used for practical cooling purposes; Sphincter pressure immediately forces it through the rectal canal and into the base of the colon. Also, Byrne and Aylot, U.S. Pat. No. 4.292,3 In No. 0.0, we created a hydrogel suppository with relatively high water content and high heat capacity. Although disclosed, the same applies to this suppository. The role of suppositories is, in principle, as a drug. It is said that it has a cooling effect on the rectal canal, or that it is expected to have a cooling effect on the rectal canal. That has never happened before. Therefore, suppositories are generally based on prior patents as well as the present invention. This is substantially different from the disclosed rectal inserts.

Summary of the invention Free water in a hydrogel containing more than 35% water by weight has a temperature of approximately It freezes easily by lowering the temperature to below 0°C, preferably below -5°C. This is confirmed. Furthermore, this freeze-rigid body has a surface that is in contact with the skin. When the temperature reaches or approaches body temperature to the touch, the area between the skin and the frozen part of the gel is immediately removed. It has the interesting property of forming a gel film that is virtually non-freezing. This has also been confirmed.

This beneficial property prevents the introduction of pharmacologically active substances into the rectal mucosa. It can be used to treat hemorrhoids.

The present invention relates to frozen hydrogel rectal inserts, methods of making and using the same.

In the simplest embodiment of the invention, the insert is a substantially conically shaped intrarectal insert. The insertion tip and the cover, which has a larger diameter than the insertion main body adjacent to the rear end of the insertion tool. The collar is made up of a It acts to prevent hemorrhoids from curling, and thus almost all affected by hemorrhoids. It is possible to apply low temperature to the parts of the body.

The inserted insert is then held in place by the sphincter muscle itself. Including measures to prevent the release due to the original function of the muscle system and its adjacent muscular system. Various embodiments of the invention will be described in detail.

The insert of the present invention is packaged in a disposable "bubble type" package. gel-like gel within the space provided by the desired shaped bubble of the rectal insert. Hydrogel is injected.

Prior to use, the entire package is cooled by placing it in the freezer compartment of a household refrigerator. Continued Open the puff cage and, in the preferred embodiment, open the two bubble bags. The halves are separated and the cryoinstrument is removed and inserted into the patient's rectum. Most of the invention In a simple embodiment, the patient lies on his/her side in a prone position after inserting the inserter. Otherwise, the rectal musculature will attempt to expel the insert. Here, the patient is a male Become a patient. Surprisingly, for male subjects, e.g. Female subjects were unable to hold the insert in the rectum, whereas female subjects were able to do so without difficulty. It has been confirmed that it can be done.

It was with this fact in mind that we chose male patients.

Insertion of a preferred embodiment of the invention with a substantially frustoconically shaped front collar The device can be inserted with the patient seated, and the device can be inserted between the back of the collar and the sphincter. It can be held by interaction with the inner surface.

The insert may remain in place for 1 to 5 minutes before being removed or left in place. If you leave it in place, the insertion part will melt due to the action of body temperature and sphincter pressure, causing the sphincter muscle to tighten. The undissolved portion inside is retained and passes into the colon.

The hydrogel itself used as a component of the rectal insert of the present invention has physiological effects. The gel, sol or solution produced as described above will not be used during the next defecation process. It remains in the colon without causing any physiological discomfort until it is removed.

Brief explanation of drawings FIG. 1 is a plan view showing a specific example of the rectal insertion instrument according to the present invention.

FIG. 2 is a plan view showing another embodiment of the present invention and its package.

FIG. 3 is a lateral cross-sectional view of a package containing the rectal insert of FIG. 1;

FIG. 4 is a sectional view along the line 4-4 of FIG. 1, and shows a specific example of the improvement.

FIG. 5 relates to the present invention. A specific example having a simple form of a rectal insert is shown.

FIG. 6 shows an embodiment of an insert according to the invention which is particularly suitable for drug delivery.

Figure 7 shows a book consisting of a handle and a collapsible insert filled with hydrogel. FIG. 2 is a perspective view showing a specific example of the invention insertion device.

FIG. 8 shows that the insert part has a hydrogel part and an almost rigid part for the hydrogel part. 3 shows an example of another package of the invention consisting of a composite carrier and a blocking part; FIG.

Detailed description of preferred embodiments The rectal insert of the present invention preferably has a shape that is not unique to the rectal insert. Blister-shaped puff with pre-fitted blisters The blister is marketed as a cage, and the blister contains hydrogel in the proportions described below. It is filled with a gel consisting of polymer and water.

The choice of blister bag type depends on the release conditions and the nature of the gel used. Ru. Gels with a moisture content of 35 to 90% have strong shape retention and have almost no molding effect. It can be packaged in a different package. Gels with a water content of over 90% will take shape at room temperature. unable to maintain. Such gels are made of polyvinyl chloride (PVC), polyvinyl chloride (PVC), Stored in a nearly rigid molded blister bag made of materials such as Listyrene. be able to. Alternatively, a polyethylene “soft” blister bag may be used. If necessary, apply heat to soften this and apply gentle pressure to inject the gel. You can also.

The package is cooled to a temperature below the freezing point of water prior to use. Generally -5℃ It is best to use a general household refrigerator with a cooling capacity of -15°C. Good too.

One of the advantages of the present invention is that even with this stronger cooling, frostbite and other problems can occur during use. It is important not to cause any bad effects.

This advantage is due to the properties of water-swellable polymers (preferably hydrogels) . In the case of ice, when it touches a warm surface such as the skin, the outermost layer melts and turns into water, which can enter the rectum. If pressure is applied, as in Contact will cause frostbite. On the other hand, when a gel is frozen, the ice and gel phase Separation occurs. When the surface layer of ice melts, the resulting water remains in the gel. The temperature of this layer does not drop below 0°C and the layer is in contact with the internal frozen surface. prevent contact. Rectal inserts may be liquid at room temperature or self-maintaining. However, here we will explain the frozen rectal insert.

When using a rectal insert to treat hemorrhoids (as described later, the purpose of use is to treat hemorrhoids). (not limited to treatment of hemorrhoids), maintain contact between the cooling surface and the hemorrhoidal tissue for as long as possible. It is very important to. Generally, treatment time is required to be at least 1 minute, but when contact It is desirable that the interval be 5 minutes or more.

An important consideration with this treatment is that the hemorrhoidal veins are located within and around the sphincter. It is present within the rectum itself as well as externally. Therefore, successfully To use a tool, it must be possible to maintain contact on all parts. do not have. Therefore, conventional herbal medicine devices that easily pass through the sphincter and advance into the rectum are , because the contact time is too short, it can be used for chemotherapy of hemorrhoids, but it cannot be used for thermal treatment. It is not suitable for

The simplest example of the device of the present invention is shown in FIG. This rectal insertion device (500) is a generally cylindrical central body (510) with a conical tip (512); 532) and a stopper part (530). When using the equipment The tip (512) passes through the sphincter of the rectum, and the front (532) passes through the sphincter. Penetrates to the point where it touches the outside of the Leave the insertion tool in place and let it dissolve completely. Otherwise, wait until sufficient time has elapsed before taking it out.

When the user is seated, the pressure exerted by the sphincter of the rectum and its adjacent muscles attempts to eject the inserted object. Therefore, use the equipment shown in Figure 5. If this is the case, it will be necessary to constantly apply inward pressure to the device, but this This is difficult and also undesirable in terms of appearance. Instead of sitting up, the patient should lie on his or her stomach. Devices can be easily inserted and retained in the crawling position. however Even in that case, towels etc. should be used to prevent contamination of the bed by the fusion insert. This is not desirable in terms of appearance. However, despite these difficulties, , this simple device can be used effectively.

A further preferred embodiment of the present invention is an apparatus in which the improvements shown in Fig. 4 are added to the apparatus shown in Fig. 1. Can be mentioned.

In the frozen state, the device is generally cylindrical with a hollow conical tip (112). It consists of a rectal insertion part (100) with a shape (110). The cylindrical part (110 ) has a collar (114) at the rear of the collar (114), which allows the collar to penetrate into the sphincter. a front face (114) of generally frustoconical cross section to facilitate insertion; a rear surface (118) to prevent the device from being ejected out of the sphincter; It is highly desirable to have one. Following the collar (116) is a generally cylindrical intermediate section (120). ). At the rear of this intermediate part (120), a front buffer surface (132) and a rear surface (13 4) is provided. Color (130) is the vessel Acts as a stopper to prevent the entire device from entering the sphincter muscle There is no need to completely enclose the device. However, the color (130) is the instrument. It is also easy to create a shape that completely encloses the Ra (130) is strengthened.

A holding part (140) is provided after the stopper (130).

The addition of this section is for convenience only and does not affect the functionality of the device itself. It is not an important influencing factor. The equipment may be equipped with various conveniences as necessary. and, if desired, both sides of the holding part (140), as shown in FIG. If you shave it to make it almost parallel (142), you can easily insert/remove the device with two fingers. You can have it. Similarly, from cloth, plastic, wood or other suitable materials. A retaining means is provided on the retaining portion (140) and protrudes therefrom to facilitate insertion/insertion of the instrument. It can be used as a drying surface for handling during removal. These are also just conveniences This is a means above, and does not affect the essential function of the device itself. After inserting By melting the frozen hydrogel, the front collar (116) (but only this The outside diameter of the device, including but not limited to To the extent that it self-releases, i.e., the device is easily removed from the sphincter. Consideration is being given to reducing the size to .

However, the entire insertion part in front of the middle part (L20) is held within the rectum, and the cooling effect is When it is desirable to advance into the colon like traditional herbal medicines after the fruit is almost complete. There is a case.

Pharmaceutically active compounds that can be administered rectally must be administered in pharmacologically acceptable amounts. Such devices are particularly preferred for certain treatments. An example of such a device It is shown in FIG. This device includes some of the features of the device shown in Figure 1 and some of the features shown in Figure 5. Some of the features of each instrument are utilized. However, the equipment (600) shown in Figure 6 What is particularly noteworthy about this is that the middle part (620) is very thin, and its diameter is smaller than that of the front part. This means that it is 25 to 75% of the body (110). The sphincter muscle is this thin middle If the insertion tool is in the Advance the insertion tube through the colon as previously described by breaking the anterior portion prior to lysis. Needless to say, let's do it. An improved version of this device is the front collar. An example is one in which (614) is omitted (not shown).

As previously mentioned, instruments do not, or rarely do, retain their shape at room temperature. It may be in a gel-like form. Packaging instruments in this way is convenient and allows for immediate use. Disposable blister packs eliminate the need to keep instruments frozen. Convenient to use as a cage. However, thermoformable systems of thermoplastic materials It is particularly preferable to use

Modifications of this package are shown in FIGS. 2 and 3. This package (256 ) is a pair of pre-shaped blister sheets (254) and (252). (252 is not shown).

The edges of this sheet are sealed with a heat seal (256).

To make this device, gel material is emptied through hole (250) by conventional means. (210) and then complete the seal.

To make opening the package easier, add a notch (258) or perforation line if desired. (262) etc. can be provided. As mentioned above, the package (256) It is noteworthy that it only seals the edges of the flat. Other unsealed connections The contact is not an important matter for the present invention (also, this flat part cannot be sealed by heat sealing or the like). However, if this part is left unsealed, the device will be much easier to open. It becomes. Therefore, the heat seal (256) is a peripheral bead seal (bead 5e). al), but its position is determined by the package as long as it is around the gel material. It will be readily understood by those skilled in the art that it may be set at other locations on the page. be. As mentioned above, “soft” packaging is used for gels that are almost liquid at room temperature. When applying the ringing method, the circumferential seal should actually be formed along the annulus of the inserter. It is.

The insertion tool illustrated in FIG. 7 includes a handle portion (730) and a number of orifices (71 1) and a tubular part (710). Handle part (730), tubular part ( 710), the equilibrium swelling with water is 73%. A multi-block copolymer hydrogel of acrylonitrile and acrylamide Soft collapsible materials such as Such hydrogel polymers are inexpensive. Although preferred because of its properties, other polymers and rubbers can also be used.

Place this part of the device in a mold similar to that shown in Figures 2 and 3. The hydrogel, preferably having a water content of 90% by weight or more, is injected into the mold, and the tubular part is (710) is filled with this hydrogel. This device can be frozen in the normal way. then insert it in the normal way.

The device shown in this example can be used with the patient in a supine position or with the patient in a sitting position. However, due to the shape of the handle, it may not look like the instrument shown in Figure 5. Many of the difficulties have been resolved. As the insertion part of the device warms up, it dissolves and the rectal muscles The gel is forced out of the orifice (711) by the combined pressure of After the time has elapsed, the device can be removed and thrown away. This device can be administered rectally It is particularly suitable for the simultaneous administration of pharmacologically active substances and, due to its structure, 1 There is no risk that remaining carrier parts may be reloaded or reused after multiple uses. do not have.

FIG. 8 shows another embodiment of the invention. This instrument consists of a handle (840) and a rear The material of the collar (830) is made of a material other than hydrogel. In this example The pan cage is a regular blister pack sealed with a peripheral heat seal (856). It consists of (854)/(852). Inside the bubble are the handle part (840) and the rear part. There is a rear section consisting of a collar (830). The purpose is to ensure stability during use. and a small bar or plug (835) is attached perpendicular to the longitudinal axis. There is a longitudinal projection (836) that connects the gel portion of the inserter to the handle. Premature separation with the dollar part is prevented.

After injecting the hydrogel into the puncture (854) through the hole (850), the pack (854) ) is sealed in the usual way.

In the example shown in Figure 8, the front collar (114) as shown in Figure 1 is not shown. However, this front collar (preferably frozen hydrogel) is easy to apply. Ru. The method of use of the inserter shown in Figure 8 is the same as that of the instruments shown in Figures 2, 5, and 7. It is. Non-hydrogel handle and rear collar for aesthetic reasons It would be more desirable to Some manufacturing steps include inserting this into the package before injecting the hydrogel. The additional steps increase the cost of the insert.

The hydrogel rectal insert of the present invention includes: a) The diameter of the trunk is approximately 5 to 15 m, the length is approximately 35 to 125 m, and the equilibrium moisture content is is about 35% by weight or more, preferably 90% by weight or more, most preferably 95-99% by weight. %, and most of the swelling water consists of hydrogel that freezes at 1°C to ÷1°C. a torso having a substantially cylindrical shape that is inserted into the rectum in a frozen state; b); Preferably, the non-insert material is firmly attached to the body, at least in frozen conditions. Consists of an entry end.

This non-inserted end may consist of a hydrogel collar as described above. However, this material is not limited to hydrogels, but also wood, plastic, cardboard, etc. It can be any hard material.

The hydrogel described above swells in water until it reaches a certain equilibrium water content, but at room temperature and in the body. It is a crosslinked or non-crosslinked polymer that is insoluble in water at high temperatures. Equilibrium moisture content at room temperature is more than 35% by weight in the swollen hydrogel, and most of the swelling water is in the free state. It crystallizes just like water itself. Importance of the hydrogel used in the present invention One of the characteristics is that the water is composed of hydration water that does not freeze and free water that freezes at around 0℃. There are two states: Most of the water in hydrogels that can be used in the present invention crystallizes near temperatures below 0°C, and the remaining water hydrates the polymer molecules. (For more information on free, mobile, and bound aqueous phases in hydrogels, see e.g. For example flr+dronikashvili etc.; Biopolymers, 1 976, 15.1991).

The main role of the mobile aqueous phase is to cover most of the heat capacity and keep the surface of the melted hydrogel close to 0°C. The goal is to maintain a low temperature (but not below 0°C).

Bound water plasticizes the brittle polymer (a mixture of ice crystals and unplasticized polymer , as fragile as ice itself, if not more so).

Hydrogels with a swelling water content of only about 35% can also be used in the present invention; It is desirable to use 70% or more hydrogel. If the moisture content is over 70% Even when the gel is homogeneous, mobile water is far superior to bound water. Transfer The moving water has a cage-like structure (cage-1ike　5structure), If the pores or water volume spaces are less than 40-50 angstroms, they will not fully develop. do not have. The proportion of this small intermolecular space decreases in proportion to the swelling capacity, and the water content is approximately 70%. %, large pores dominate even in the case of hydrogels with high intrinsic binding capacity. .

The inventors have shown that the freezing properties of some hydrogels with a swelling capacity of 35-70% water are We confirmed that it depends to some extent on its preparation, thermal history, etc. this On the other hand, hydrogels with a water content of about 70% or more are hardly affected by these effects.

Furthermore, both heat capacity and thermal conductivity are exponential rather than linear with increasing moisture. As the numerical value increases and the water content exceeds about 70%, the contribution to the thermodynamic properties of moving water increases. It is easy to see that the contribution of As expected.

Any polymer having a swelling capacity of 70% or more in water can be used in the present invention; Examples include niacrylamide, methacrylamide and their Polymers and copolymers of these N-substituted derivatives; acrylic acid, methacrylic acid Polymers and copolymers of acid, maleic acid and itaconic acid; 2-hydroxy Acrylic acids such as ethyl methacrylate, glyceryl acrylate, etc. Polymers and copolymers of parent wood esters of alcohol and methacrylic acid; Polymers and copolymers of lysine and vinylpyrrolidone; poly(ethylene) For polyether polycondensates such as glycose and poly(propylene) glycose, and their grafts or block copolymers; polysaccharides such as starch; Derivatives such as ululose and methylcellulose; collagen, elastin, gela polypeptides such as chin; mixtures containing substantially hydrophilic polymers such as those mentioned above; thing.

The hydrogel can be prepared by known methods depending on the type of polymer, e.g. difunctional copolymer. Can be crosslinked by copolymerization with polymers, by aldehydes, or by irradiation. Ru.

Non-crosslinked hydrogels, even though water-insoluble, are generally preferred due to their superior processing properties. preferable.

Particularly preferred hydrogels are derived from poly(acrylonitrile) and contain amide and/or hydrogels with carboxyl functional groups. Hido like this There are several types of logels, one of which is, for example, U.S. Patent No. Block copolymers of acrylonitrile as described in No. 337.327 There are some that contain

Other types, such as starch, are grafted with acrylonitrile. There are polysaccharides that have been hydrolyzed. There is a large literature on this type of hydrogel. (for example, 14.Q, 14erver, etc., Journal o f Applied Polymer Science, Vol, 15. pp, 3015-3024 (1971)).

Similar copolymers are described in the Journal by, for example, G, F, Fanta, etc. of Applied Polyller 5science, Vol, 1 6.2835-2845 (1972), acrylamide can be obtained by directly grafting onto starch. Hydroge above forms a hydrogel with very low solids content and very high water content which can be frozen. can be done. This hydrogel is extremely soft in the dissolved state and also exhibits swelling properties. We are prepared.

The present inventors have made the main part of the insertion device under water with a moisture content of 90% or more, preferably 98% or more. We found that it is advantageous to form hydrogels with the following properties: (1) In a plastic packaging foil in a melted state in the temperature range of 0-50℃ It has enough strength to maintain that state, and on the other hand, it reduces the pressure on the sphincter muscles. When exposed, it loses its shape, and when dissolved, it becomes a lubricating jelly; (2) The amount of swelling in water increases significantly in proportion to the temperature; (3) 50-10 Soluble in the presence of water at a temperature of 5°C.

Examples of such hydrogels include: ~99.7% acrylonitrile-acrylamide multiblock copolymer; Water-containing gelatin; starch gel; mixtures thereof.

There are several advantages to using hydrogels. The first is The collapsible hydrogel is said to form a lubricious (dissolving) layer on the surface of the frozen insert. That is true. The second is that the hydrogel dissolves and collapses within the rectum. Reuse becomes impossible and at the same time a protective swelling layer forms on the surface of the rectal tissue. That is true.

The third is heat transfer between the rectal tissue and the frozen core of the insert due to the collapse of the lysed layer. This means that the results will be improved. The rectal tissue and the core of the insert are at approximately constant temperature; By crushing the Drogel, through the hydrogel layer with constant thermal conductivity and thickness. The heat transfer that takes place is guaranteed.

If the swelling capacity increases with increasing temperature, a certain amount of free water will be released during the dissolution process. It will be done. Water and excess dissolved hydrogel are forced from the rectum into the base of the colon. This softens the stool and protects the rectal tissues during defecation.

In addition, collapsible hydrogels have a much longer straight time than the insert itself. It has the advantage of remaining in the intestine.

The cooling effect of the insert only lasts for a few minutes, but the lubricating/therapeutic effect of herbal medicine for hemorrhoids lasts for several minutes. It must last for a longer period of time. Therefore, crushable hydro By using a gel, the functions of a cooling insert, herbal medicine, and ointment can be combined into one. This can be done with equipment.

The main purpose of the present invention is to reduce hemorrhoids by cooling the area around them. , as an additional means of hemorrhoid treatment or also as a means of obtaining the desired physiological effect. According to the present invention, a pharmaceutically acceptable amount of a pharmacologically active compound that can be administered rectally is prepared in advance. It is also possible to use it as a drug administration system by incorporating it into a rectal insert device related to It is within the technical scope of the present invention.

Once administered, the drug will either dissolve in the aqueous phase or in the hydrogel depending on its water solubility. dispersed into The following drugs are particularly effective in relieving symptoms of inflammation and swelling: It is effective. Dexamethasone, hydrocortiscin, phenylbutacin, or pre- Donizolone; local anesthetics such as zenadipyridine, or procaine; phenyl Tissue contracting agents such as propatoolamine, constituents; shark liver oil, yeast induction A natural substance used in ointments for hemorrhoids, such as on the body, or in herbal medicine.

Water-insoluble substances can be dissolved in an oily substance (such as a regular rectal ointment base) and then Can be dispersed in a gel. The majority of hydrogels are used as oil-in-water dispersions. As long as the oil is used, it will not interfere with the freezing process. Oily substances It also has the effect of promoting drug lubricity and movement into tissues. these drugs The concentration and dosage of these drugs are almost the same as those of conventional herbal medicines using these drugs. Same (Physicians Desk Reference tl, s , Pbarmacopoea, etc.).

Example Example 1 2-Hydroxyethylmethacrylate containing 0.7% ethylene glycol dimethacrylate 40 parts by weight (W/W) of taacrylate monomer, 60 parts by weight (W/W) of water, and 0.5 parts by weight (W/W) of 30% hydrogen peroxide, and the mixture was coated with polyethylene. Polymerization was carried out at 65°C in a plastic mold. After the polymerization reaction is complete, open the mold and remove the polymerized product. was thoroughly washed with water. As shown in FIG. 5, the insertion barrel ( 510), and a non-insertable large diameter end (530). The tube was packed in heat-shrinkable plastic foil. The water content of the hydrogel itself is 60%. Approximately 20% of this water was contained in the microscopic mold pores as freezable water.

Example 2 It is made of acrylonitrile and acrylamide and contains 73% equilibrium swelling water. injection molded copolymer hydrogel with multiple orifices as shown in Figure 7. The hollow tubular body was provided with a handle-like end portion (732) and a handle-like end portion (732).

of starch grafted with acrylonitrile and then hydrolyzed with sodium hydroxide. After washing and drying 1 part of powdered copolymer (W/W), 5 parts of potato starch (W/W) and 100' parts of water (W/W), and the paste was heated to 100'C. It was heated to liquefy.

Next, the above-mentioned high-temperature liquefied paste is poured into the cavity of the hydrogel hollow tubular body (710). After filling, it is cooled and gelled.

The outer wall (715) of the hydrogel hollow tubular body (710) has a moisture content of 73%. Thermal conductivity is lower than that of the interior, which prolongs the duration of the cooling effect and at the same time improves operation efficiency. It works to protect the weak internal gel during transportation and handling. inside the appliance The gel collapses under rectal pressure and is forced out of the jacket through the side and distal holes. be done. Internal gel dissolves and acts as a lubricant and sometimes as a drug carrier After remaining in the body, the external hydrogel jacket is withdrawn through the anus.

Oshi■1 Mix polyacrylonitrile with a molecular weight of 350.000 with 71% nitric acid and 98% sulfuric acid. (9: IW/W) to form a viscous solution with a solid content of 5% (W/W). Ta. This solution was left for 240 hours to almost completely hydrolyze the nitrile groups, and then The polyacrylonitrile melt (PAN) was solidified by pouring into excess cold water. flat After thoroughly washing this transparent soft gel with an equilibrium swelling water content of 95% or more with water and drying it, it becomes a fine powder. It became.

Add 7.5 parts (W/W) of PAN hydrolyzate powder to 990 parts (W/W) of water until boiling point. Heat was applied to dissolve the powder. The resulting solution is cooled to room temperature to gel, and a moderate A transparent soft gel that collapses under pressure was obtained.

As shown in Fig. 3, a two-piece mold made of PVC foil with a thickness of 0.0075 is used. prepare. Assemble the half parts (352) and (354) and insert the injection port into the internal cavity. (350) (not shown, but the same as the injection port (250) in Figure 2) Inject a hot solution of The solution is then cooled in a water bath and the injection port is sealed. PVC Jacket (can be divided into two parts (352) and (354) ) and an internal soft hydrogel, the finished product is cooled to -15° C. before use. Hi After the Drogel has frozen, soak the insertion device in warm water for a while and insert it under the PVC jacket. A thin gel layer may be melted. Separate the two parts (352) and (354), Insert the insert into the patient's rectum.

Senban charcoal↓ Shark Liver Oil 3%, 2000 units of skin respiratory factor per ounce of ointment Live yeast derivatives that can ensure respiratory factor), Acid phenylmercuric products H (Whitehall 1 aborato-ries Inc., N. York) 5 parts of rectal ointment containing 0.01% The high temperature dispersion was finely dispersed in 95 parts of the high temperature polymer aqueous solution obtained in Example 3. The mixture was filled into a two-part molded container and gelled to form a solid dispersion.

Dissolve 21 parts of procaic hydrochloride and 1 part of phenylbutacin in 98 parts of 1% polymer aqueous solution. (The polymer is the powdered polymer described in Example 3). Inject this hot solution Inject into the mold/container (854) through the port (850) and mix with the collar (830). Filling the entire space (810) between the PVC foil container and the drug-loaded hydrogel. . The injection port (850) was then fused to seal the container.

Engraving (no changes to the content) Figure 1 Figure 2 Figure 3 Figure 4 Figure 7 Figure 6 Figure 8 Procedural amendment document 2) March 25, 1985 Commissioner of the Patent Office 1.Display of the incident PCT/US 8310 O300 2. Title of the invention Rectal insertion device 3. Person who makes corrections Relationship to the case: Patent applicant 5. Date of amendment order: February 26, 1985 (shipment date) 6. Increase due to amendment Number of inventions: None 8, Contents of amendment (1) As per the attached document pursuant to the provisions of Article 184-5, Paragraph 1 of the Patent Act rg72]\ (2) Translation of drawings as attached international search report ” 11II meeting tIIa+onilAODl, ea11611No, PCTノ1US 8310030ONoTEX To Th-INTEPJIAT! 0NAL 5 EARCHREPORT　○＋NINTERNATIONALAPPLXCAT ION No. PCT7'US83100300 (SA4975) US-A-39 3984224102/76 NoneUS-A-1925176 None DE-C-64a690 Non= CB-A-250820Norxe

Claims (16)

[Claims] (1) Contains a gel-like water-swellable polymer containing at least 35% by weight of water, A disposable pan cage that maintains a predetermined shape, the gel being cooled to below 0°C. This provides sufficient rigidity to insert the insertion part into the rectum, and The entry section has a substantially conical tip on one side and a substantially conical tip on the other side in the frozen state. consisting of a substantially cylindrical body each having a rear collar proximate the end of the , the conical tip facilitates insertion into the rectum, and the collar ensures that the entire insert is in the rectal sphincter. A patch for the treatment of rectal diseases, characterized in that it prevents penetration beyond the diagonal muscle. cage. (2) Located behind the conical tip of the cylindrical body and in front of the rear collar. and a front collar having a substantially frustoconical section on its front surface. a plane, the rear surface of the anterior collar being positioned in a plane substantially perpendicular to the longitudinal axis of the inserter; a substantially cylindrical shape between the rear surface of the front collar and the front surface of the rear collar; The puff cage for treating rectal diseases according to item (1) above, wherein the puff cage is provided with a shaped middle part. . (3) The rear collar is spaced a sufficient distance forward from the rear end of the insertion tool. As stated in paragraph (1) above, the remaining rear part can be held with the fingers. package for the treatment of rectal diseases. (4) At least a portion of the rear curved surface is flat and approximately parallel to the longitudinal axis of the insertion tool. The package for treating rectal diseases according to item (3) above, which is in a substantially parallel plane. (5) The diameter of at least a portion of the intermediate portion is smaller than the maximum diameter of the tip portion. The package for treating rectal diseases according to item (2) above. (6) The diameter of the intermediate part is 50 to 25% of the maximum diameter of the tip part (5). Panpackage for the treatment of rectal diseases described in section ). (7) The diameter of the front collar is 150 to 250% of the maximum diameter of the tip. The package for treating rectal diseases according to paragraph (2). (8) Rectal disease described in item (1) above where the water content of the gel is low (both 90%) treatment package. (9) The rectum according to paragraph (7) above, wherein the water content of the gel is at least 98% by weight. Package for disease treatment. (10) The device is made of acrylonitrile acrylic with a moisture content of 95 to 99.7% by weight. Rectal disease treatment according to item (8) above, comprising a multi-block copolymer of amides. package for. (11) Items listed in (1) above, including the pharmacologically acceptable amount of the rectally administrable pharmaceutically active compound. A package for the treatment of rectal diseases. (12) Made of a water-swellable polymer containing 35% by weight or more of water, it passes through the rectal sphincter muscle. An insertion tool with a shape and size that allows for easy insertion is prepared in advance for a sufficient period of time. By cooling to a temperature below 0°C, the free water inside is frozen and the disease is removed. the inserter into the person's rectum, with at least a portion of the insert outside the sphincter muscle. (A hemorrhoid treatment method characterized by holding both for 1 minute. (13) a distal end having a substantially conical shape for insertion; and a distal end located close to the rear end; have a diameter larger than the maximum diameter of the end to prevent the entire insert from penetrating into the sphincter. An approximately cylindrical insert with a collar that acts to prevent hemorrhoids is inserted into the rectum of a person suffering from hemorrhoids. The method for treating hemorrhoids according to item (12) above, which comprises inserting the hemorrhoid. (14) The insertion device according to paragraph (12) above, wherein the moisture content of the insertion device is at least 90% by weight. Hemorrhoid treatment method. (15) The moisture content of the insertion device is at least 98% by weight as described in item (14) above. How to treat hemorrhoids. (16) The insertion tool is made of acrylonitrile acrylic with a moisture content of 95 to 99.7%. The method for treating hemorrhoids according to item (12) above, comprising a multi-block copolymer of amide. Law. Agent: Patent attorney Arata Miyazaki Department